Consensus(Tm) Total Hip System
FDA 510(k) K922561 · U.S. Medical Products, Inc.
510(k) numberK922561
Submission
- Device name
- Consensus(Tm) Total Hip System
- Applicant
- U.S. Medical Products, Inc.
Austin, TX, US - Received
- June 3, 1992
- Decision date
- July 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3320
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | Zimmer, Inc. | 08/07/2008SE |
| K070785 | Dynasty Acetabular SystemJDL · Special | Wrightmedicaltechnologyinc | 07/11/2007SE |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special | Wrightmedicaltechnologyinc | 12/06/2006SE |
| K051995 | Profemur Renaissance Hip StemJDL · Special | Wrightmedicaltechnologyinc | 08/22/2005SE |
| K051348 | Conserve Total Femoral HeadJDL · Traditional | Wrightmedicaltechnologyinc | 08/19/2005SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | Biomet, Inc. | 12/21/2004SE |
| K041586 | Profemur S Hip StemJDL · Special | Wrightmedicaltechnologyinc | 07/09/2004SE |
| K041114 | Profemur Tapered Hip StemJDL · Special | Wrightmedicaltechnologyinc | 05/28/2004SE |
| K004043 | Metal Transcend Articulation SystemJDL · Abbreviated | Wrightmedicaltechnologyinc | 07/13/2001SE |
| K950542 | Metal Backed Acetabular ComponentJDL · Traditional | Encore Orthopedics, Inc. | 05/25/1995SE |
More from Encore Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962215 | Consensus Posterior Stabilized Knee-Intercondylar Notch RouterHWE · Traditional | 08/15/1996SE |
| K954818 | Consensus Posterior Stabilized KneeJWH · Traditional | 05/22/1996SN |
| K953443 | Consensus PCL Subsituting Tibial InsertJWH · Traditional | 04/26/1996SE |
| K960302 | Consensus Acetabular Shell, All UhmwpeJDI · Traditional | 04/01/1996SE |
| K952943 | Consensus All Poly TibiaJWH · Traditional | 04/01/1996SE |
| K960340 | Consensus Apex Dome Hole PlugJDI · Traditional | 03/15/1996SE |
| K960339 | Consensus 22MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960156 | Consensus 32MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960151 | Consensus 26MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K955386 | Consensus Zirconia Femoral HeadLZO · Traditional | 02/20/1996SN |
Questions and answers
When was Consensus(Tm) Total Hip System cleared by the FDA?
Consensus(Tm) Total Hip System (K922561) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 413 days after the submission was received.
What is the product code of K922561?
The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.